Track topics on Twitter Track topics that are important to you
In this 6-month randomized, controlled trial, we will evaluate the impact of genetic testing for type 2 diabetes on psychological, health behavior, and clinical outcomes. Results from this study will inform the VA whether genetic counseling can be effective for communicating disease risk, motivating behavior change, and, ultimately. preventing a complex, chronic disease (type 2 diabetes). If genetic risk counseling successfully augments conventional risk counseling, this study would provide a model for incorporating genetic testing for type 2 diabetes into primary care at the VA.
T2DM is a debilitating, deadly, and costly chronic disease whose prevalence is increasing. Although the development of T2DM can be delayed or prevented by lifestyle changes, changes initiated too late may not delay T2DM onset indefinitely. Therefore, it is imperative to intervene earlier and to find new ways to increase motivation to initiate and maintain lifestyle changes.
New approaches to primary prevention could incorporate tests for genetic and genomic risk of T2DM, creating a sizable and growing opportunity for the translation of such tests into primary care and public health practice. However, the ability for these tests to demonstrate improvement in patients' health outcomes remains unknown, posing a major obstacle to further translation. In this 6-month randomized, controlled trial, we will evaluate the impact of genetic testing for T2DM on psychological, health behavior, and clinical outcomes.
Eligibility criteria include age 21 to 65 years, overweight or obese (body mass index [BMI] >27 kg/m2), and no prior diagnosis of T2DM. At baseline, participants (N=600) will have conventional risk factors assessed, including demographics, fasting plasma glucose (FPG), and family history. They will also provide cheek tissue samples for genetic testing of TCF7L2, PPARG, and KCNJ11, three genes that confer elevated risk for development of T2DM. Participants will then be randomized to receive conventional counseling only (CR) or conventional counseling plus genetic test results (CR+G). One to two weeks following the baseline visit, when the genetic test results are available, participants will return for a visit with a genetic counselor. All participants will receive conventional risk counseling based on their lifetime population risk, FPG results, and family history. Next, participants will be informed of their randomization assignments; CR participants will receive general health risk counseling on issues unrelated to T2DM, whereas CR+G participants will receive genetic counseling. Then perceived risk, affect, self-efficacy, and readiness to change will be assessed. All other outcomes will be assessed at 3 and 6 months.
Enrollment scheduled to begin in early August, 2010.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
genetic testing for type 2 diabetes, Conventional risk counseling for type 2 diabetes
VA Medical Center
Not yet recruiting
Department of Veterans Affairs
Published on BioPortfolio: 2014-08-27T03:16:14-0400
The primary objective of the study is to assess the clinical utility of a genetic test for Type 2 diabetes risk in combination with standardized risk assessment compared with standardized ...
This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. Intervention subjects will be provid...
The objective of this study is to determine the percentage of children with genetic markers putting them at increased risk of developing type 1 diabetes, and to offer the opportunity for t...
Type 2 diabetes is a common metabolic disorder arising from a complex interaction between genetic predisposition and the environment. The development of this disorder is preceded by impair...
5-10% of breast cancer patients carry a mutation in the BRCA1 or BRCA2 gene. Genetic counseling and DNA testing are usually offered to selected patients after primary treatment has been co...
Around 0.3% of newborns will develop autoimmunity to pancreatic beta cells in childhood and subsequently develop type 1 diabetes before adulthood. Primary prevention of type 1 diabetes will require ea...
We hypothesized that diabetes-related distress would vary by type of diabetes and medication regimen [Type 1 diabetes (T1DM), Type 2 diabetes with insulin use (T2DM-i), Type 2 diabetes without insulin...
We examined the proportion of American adults without type 2 diabetes that engages in lifestyle behaviors known to reduce type 2 diabetes risk.
Causality has been demonstrated for few of the many putative risk factors for type 2 diabetes (T2D) emerging from observational epidemiology. Genetic approaches are increasingly being used to infer ca...
Type 2 diabetes mellitus is a multifactorial metabolic disorder caused by environmental factors and has a strong association with hereditary issues. These hereditary issues result in an imbalance in C...
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
An organized and comprehensive program of health care that identifies and reduces a woman's reproductive risks before conception through risk assessment, health promotion, and interventions. Preconception care programs may be designed to include the male partner in providing counseling and educational information in preparation for fatherhood, such as genetic counseling and testing, financial and family planning, etc. This concept is different from PRENATAL CARE, which occurs during pregnancy.
A severe type of hyperlipidemia, sometimes familial, that it is characterized by the elevation of both plasma CHYLOMICRONS and TRIGLYCERIDES contained in VERY-LOW-DENSITY LIPOPROTEINS. Type V hyperlipoproteinemia is often associated with DIABETES MELLITUS and is not caused by reduced LIPOPROTEIN LIPASE activity as in HYPERLIPOPROTEINEMIA TYPE I .
The joining of RNA from two different genes. One type of trans-splicing is the "spliced leader" type (primarily found in protozoans such as trypanosomes and in lower invertebrates such as nematodes) which results in the addition of a capped, noncoding, spliced leader sequence to the 5' end of mRNAs. Another type of trans-splicing is the "discontinuous group II introns" type (found in plant/algal chloroplasts and plant mitochondria) which results in the joining of two independently transcribed coding sequences. Both are mechanistically similar to conventional nuclear pre-mRNA cis-splicing. Mammalian cells are also capable of trans-splicing.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...